Kornimate/medical-research-clean huggingface dataset:
evaluation of pku explore

Conditions: Phenylketonuria; Inborn Errors of Metabolism

Summary: to evaluate the acceptability, tolerance and effect on metabolic control of pku explore, a renovated phe free protein substitute for the dietary management of pku in children from 6 months to 5 years.

this is a prospective, acceptability study to evaluate the gastrointestinal tolerance, palatability and adherence of pku explore in a four-week period for 15 participants aged between 6 months and 5 years for the dietary management of pku. the outcome of this assessment will be used in a submission to the regulatory authorities, advisory committee on borderline substances (acbs), for pku start to become reimbursable on prescription in the uk. the participant's dietitian will advise on an appropriate amount of pku explore based on individual requirements. parents/carers will be asked to substitute their usual phe-free protein substitute with pku explore for one (1) month. the sponsor will supply pku explore free of charge. parents/guardians will be asked to record information about the following: daily pku explore intake stools vomiting and spit-up feed / fluid intake compliance phenylalanine levels (from their routine blood spot testing) final evaluation about the presentation of the product, ease of preparation and use.

Eligibility criteria:
inclusion criteria: i. a diagnosis of pku on new-born screening requiring a low protein diet and phe-free l-amino acid supplements. ii. aged between 6 months and 5 years. iii. already taking a second stage concentrated protein substitute as part of their pku management or is at the stage in their pku management when a second stage concentrated protein substitute is recommended to commence. iv. willingly given, written, informed consent from parent/guardian. v. willingly given, written assent (if appropriate). exclusion criteria: i. diagnosis of persistent hyperphenylalaninaemia, or mild pku not requiring dietary treatment with a low protein diet and phe-free l-amino acid supplements. ii. diagnosis of a concurrent condition which may adversely affect developmental progression and feeding ability. iii. participation in any other clinical trial/acceptability study. iv. any serious medical precluding the study intervention. v. use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).

Keywords: phenylketonuria pku metabolism metabolic control acceptability
post operative rt for limited spine metastases

Conditions: Spine Metastases

Summary: to evaluate patients with limited spine metastases treated with total spondylectomy followed by conventional radiotherapy or debulking surgery followed by sbrt or conventional rt. the study primary endpoint is one year local control.


Eligibility criteria:
inclusion criteria: 1. patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery. 2. patients with maximum two continuous level of spine metastases need for surgery are eligible. patients who have other spine metastases but not necessary for surgery are allowed. 3. a preoperative gadolinium enhance mri should be obtained up to 8 weeks before enrollment. 4. patients aged at least 20 years old are eligible. 5. life expectancy of ≥ 6 months. 6. ecog performance status 0-2 (ecog 3-4 related to cord compression can be enrolled after physician assessment) 7. no prior rt to the index spine level(s) 8. women of childbearing potential must practice adequate contraception 9. patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent. exclusion criteria: 1. patients received prior radiotherapy to the index spine level. 2. patients who cannot receive gadolinium enhanced mri due to pacemaker or metal implant or who cannot receive contrast enhanced ct scan due to impaired renal function. 3. patients who have hematological cancer or primary spine tumor will be excluded for enrolment. 4. patients who cannot tolerate radiotherapy immobilization. 5. severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows: 1. uncontrolled active infection requiring intravenous antibiotics at the time of registration 2. transmural myocardial infarction ≤ 6 months prior to registration. 3. life-threatening uncontrolled clinically significant cardiac arrhythmias. 4. hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. 5. chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. 6. uncontrolled psychiatric disorder. 6. pregnant or breast-feeding women

Keywords: stereotactic body radiotherapy spondylectomy separation surgery
telerehabilitation-based early upper extremity training in stroke patients

Conditions: Stroke, Acute

Summary: telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic.

after the sociodemographic data of the participants are recorded, mini mental test (mmt) will be applied to evaluate the cognitive status. upper extremity functions of patients eligible for the study will be evaluated with the fugl-meyer upper extremity scale (fm-ue), proprioception evaluation will be evaluated with the laser-pointer assisted angle reproduction test, activities of daily living will be evaluated with the modified barthel index, and reaching performance will be evaluated with the reaching performance scale. characteristics of the patients participating in the study and all outcome measurements before and after treatment will be evaluated by a blinded physiotherapist. a researcher blinded to the exercise groups and evaluation results will perform the statistical analysis.

Eligibility criteria:
inclusion criteria: * between the ages of 30-65, with a history of stroke within the last month, * mini mental score ≥ 24, 1-10 after discharge. on the day, * patients who can sit for at least 30 seconds, exhibit a hemiparetic condition, and are clinically stable exclusion criteria: * flaccid hemiplegia detected by anamnesis and physical examination, * has spasticity in the upper extremity with a severity greater than 1+ according to the modified ashworth scale, * patients with severe dementia and dysfunction of the upper extremity joints due to a previous musculoskeletal disease

Keywords: telerehabilitation upper extremity rehabilitation proprioception
prospective memory in children with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: prospective memory (pm) is memory to complete future tasks, such as recalling to give a note to someone when you next see them, pick up milk on the way home, or remembering to keep an appointment. this study will evaluate pm in children with traumatic brain injury (tbi).

while much has been learned about how children with tbis learn and recall stories, word lists, and pictures, little is known about how they perform pm tasks. impairment in pm could have serious implications for academic and vocational pursuits. this study will investigate pm in children with mild or severe tbi. the study will focus on three major themes: 1) strategies that may help children with tbi overcome or minimize their pm deficits; 2) how specific areas of cognition can be impaired following tbi and in turn impair pm; and 3) the impact of pm deficits on a child's daily functioning, both at school and at home. the study will also evaluate children without tbi (control group). each child will participate in one study evaluation. the evaluation will last approximately 4 hours, with a lunch break and other rest breaks as necessary. assessments will include neuropsychological tests of attention, memory, and general intellectual functioning. experimental tasks will include measures of metacognition for prospective memory, elucidation of strategic versus automatic processes involved in pm, and the effect of motivation manipulations in overcoming pm deficits with varying working memory loads. the child's parent or guardian will also be asked to complete some tests to measure the impact of pm deficits on the child's daily home life.

Eligibility criteria:
inclusion criteria * english speaker * minimum birth weight of 2500 grams (5.5 lbs) and 37 weeks' gestation additional inclusion criteria for children with traumatic brain injury * head injury resulting in a post-resuscitation glasgow coma scale score of either 13 to 15 or 3 to 8 * no evidence of hypoxic injury exclusion criteria * history of epilepsy, mental retardation, or documented evidence of developmental dysfunction * previous hospitalization for head injury involving loss of consciousness or post-concussional symptoms * history of autism, major psychiatric disorder, or pervasive developmental delay * history of meningitis or encephalitis * history of child abuse * history of chronic or uncontrolled serious physical disorders (cancer, uncontrolled diabetes, cystic fibrosis, etc.) * note: siblings of participants with tbi or orthopedically-injured comparison children will not be enrolled to maintain the independence of the groups

Keywords: tbi prospective memory
cardiovascular imaging in pediatric myocarditis

Conditions: Myocarditis

Summary: this study aims to utilize cardiac magnetic resonance (cmr) to assist in the clinical diagnosis, conduct consecutive assessments for myocardial tissue in pediatrics with myocarditis, and explore effective predictive factors for adverse outcomes in pediatric myocarditis. participants will undergo baseline collection, laboratory tests, echocardiography, and cmr. all the consecutive data will be used to analyze the association with the diagnosis and prognosis of pediatric myocarditis.


Eligibility criteria:
inclusion criteria: * patients diagnosed or suspected pediatric myocarditis based on diagnostic recommendation for myocarditis in children (version 2018). * age between 1 to 18 years old. exclusion criteria: * previous history of cardiovascular disease ( e.g. congenital heart disease, cardiomyopathy, rheumatic heart disease, valvular disease ). * mri examination contraindications ; * gadolinium contrast agent contraindications ; * ct examination contraindications ; * comparison of iodine content.
the decision-cto extended 10 y follow-up

Conditions: Coronary Artery Disease

Summary: the goal of this clinical trial is to compare long term efficacy of drug-eluting stent implantation compare to optimal medical treatment in patient with chronic total occlusion in a very long-term follow-up (minimum 10 years) period.


Eligibility criteria:
inclusion criteria: 1. clinical 1) patients with angina or silent ischemia and documented ischemia 2) patients who are eligible for intracoronary stenting 3) age \>18 years 2. angiographic 1) de novo lesion chronic total occlusion (cto) 2) reference vessel size ≥ 2.5 mm by visual estimation 3) at least one cto lesions located in proximal or mid epicardial coronary artery. (if the patient has two cto lesions, one cto lesion should be located in proximal or mid epicardial coronary artery) 3. cto definition: timi (thrombolysis in myocardial infarction) flow 0 or 1 with estimated duration over 3 months * the duration of the occlusion was determined by the interval from the last episode of acute coronary syndrome, or * in patients without a history of acute coronary syndrome, from the first episode of effort angina consistent with the location of the occlusion 1. angiographically defined total occlusion over 3 months 2. if no definite symptom with total occlusion, two experienced operators decide cto in consideration of angiographical morphology (degree of calcification, bridging collaterals, non-tapered stump, angiographic filling from collaterals) exclusion criteria: 1. history of bleeding diathesis or coagulopathy 2. pregnant state 3. three vessel ctos 4. known hypersensitivity or contra-indication to contrast agent and heparin 5. st-elevation acute myocardial infarction requiring primary stenting 6. culprit total occlusion presented with acute coronary syndrome suggesting acute or recent occlusion 7. characteristics of lesion 1) left main disease 2) in-stent restenosis 3) graft vessels 4) distal epicardial coronary artery cto lesions 5) two vessel proximal segment ctos 8. hematological disease (neutropenia \<3000/mm3, thrombocytopenia \<100,000/mm3) 9. hepatic dysfunction, liver enzyme (alt and ast) elevation ≥ 3 times normal 10. renal dysfunction, creatinine ≥ 2.0mg/dl 11. contraindication to aspirin, clopidogrel or other commercial antiplatelet agent 12. left ventricular ejection fraction \<30% 13. patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 14. non-cardiac co-morbid conditions are present with limited life expectancy or that may result in protocol non-compliance (per site investigator's medical judgment).

Keywords: chronic total occlusion drug-eluting stent implantation optimal medical treatment
pediatric eye care investigated team

Conditions: Eye Diseases; Ocular Surface Disease; Systemic Disease; Children

Summary: use cohort research to analyze and compare eyes of healthy children and children with systemic diseases. understand and analyze the incidence, characteristics and influencing factors of children's ocular surface diseases. establish a multi-center children's eye data sharing platform to provide basic data support for the diagnosis and treatment of children's ocular surface diseases.

use cohort research to analyze and compare eyes of healthy children and children with systemic diseases. understand and analyze the incidence, characteristics and influencing factors of children's ocular surface diseases. establish a multi-center children's eye data sharing platform to provide basic data support for the diagnosis and treatment of children's ocular surface diseases. all participants will be recruited from zhongshan ophthalmic center, sun yat-sen university and affiliated foshan maternity \& child healthcare hospital, southern medical university. only children with written informed consent from their parents can participate in this study. participants will be excluded for (1) age\>18; (2) previous use of orthokeratology lenses or low-concentration atropine; (3) allergy to compound tropicamide eye drop; (4) any history of ocular surgery. all participants will undergo optometry and biometric measurements by a trained team. the axial length (al), central corneal thickness (cct), anterior corneal radii of curvature, anterior chamber depth (acd), lens thickness (lt), the curvature power of the central flat meridian (k1) and the central steep meridian (k2), the ocular surface and fundus will be measured. all measurements will be taken in room light condition (1000 lux).

Eligibility criteria:
inclusion criteria: * 1. age≤18 * 2. cooperate with eye examination * 3. sign informed consent exclusion criteria: * 1. cannot cooperate with eye examination * 2. the researcher believes that the patient is not suitable to participate in the study.
lam pilot study with imatinib mesylate

Conditions: Lymphangioleiomyomatosis

Summary: this is a phase 1 clinical trial comparing imatinib mesylate to placebo for individuals with lymphangioleiomyomatosis (lam).

this is a double blind, adjusted parallel design, randomized clinical trial comparing imatinib mesylate 400 mg daily or matching placebo on the primary outcome of log transformed serum vegf-d level in patients with lam. sirolimus using patients will have co-administration of imatinib mesylate or placebo for 28 days prior to sirolimus discontinuation. the duration of 400 mg imatinib mesylate or placebo will be 56 days, a dose reduction is allowed for toxicity. the primary endpoint will be the change in the log transformed vegf-d one month after monotherapy imatinib mesylate or placebo. total trial duration is 2 months of drug administration.

Eligibility criteria:
inclusion criteria: * definite or probable lam * fvc or postbronchodilator fev1 \<90% predicted exclusion criteria: * current or planned pregnancy or lactation * unwillingness to discontinue sirolimus * change in the dose or use of sirolimus within the past month * inability to perform spirometry * allergy or intolerance of albuterol and/or ipratropium * other serious illness that would impact the outcome of the study including cancer that has not received curative therapy, grade iii/iv cardiac problems as defined by the new york heart association criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study), uncontrolled diabetes, chronic renal disease, chronic liver disease, or active uncontrolled infection * current lung transplant * known diagnosis of human immunodeficiency virus (hiv) infection * current cigarette smoking * required use of warfarin, ketoconazole, itraconazole, clarithromycin, or rifampin during the 2 months of the study. * unwillingness to avoid grapefruit juice or st. johns wort during the study. * planned surgery during the 2 months of the study. * patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent. * patient has received and other investigational agents within 28 days of first day of study drug dosing.

Keywords: vegf-d imatinib mesylate sirolimus
the application value of spectral ct in the accurate staging of liver cancer

Conditions: Liver Cancer

Summary: spectral ct was used to prospectively collect medical images and clinical data related to liver cancer, evaluate the effect of image quality in the diagnosis of liver cancer, and evaluate the application value in the accurate staging of liver cancer, so as to provide a more accurate clinical basis for diagnosis, promote the development of individualized treatment, and ultimately improve the prognosis of patients.


Eligibility criteria:
inclusion criteria: 1. undergo a contrast-enhanced quark spectral ct scan of the lower abdomen/pelvis within 1 week before treatment. 2. age \> 18 years. 3. patients suspected of having liver cancer. 4. patients who have signed the informed consent form. exclusion criteria: 1. severe cardiac, pulmonary, or renal insufficiency. 2. allergy to iodine-based contrast agents. 3. inability to cooperate with the ct examination. 4. poor image quality of the quark spectral ct scan. 5. women who are pregnant or breastfeeding.
multicenter prospective cohort study of hypertriglyceridemia acute pancreatitis

Conditions: Acute Pancreatitis (AP); Hypertriglyceridemia Acute Pancreatitis

Summary: hypertriglyceridemia-associated acute pancreatitis (htg-ap) is the second leading cause in china and is receiving increasing global attention. research on htg-ap has been hindered by the heterogeneity and complexity of the disease, as well as the limitations of prior single-center studies with small sample sizes, inadequate collection of clinical data, lack of sustainable follow-up, and insufficient tools for large-scale data collection, analysis, and biomarker testing. to address these unique challenges and leverage the opportunity to gain a deeper understanding of htg-ap, the china hypertriglyceridemia pancreatitis study group (chpsg) was initiated in april 2023 as a multi-center collaboration. by utilizing the advantages of multi-center studies, such as external validity and larger sample sizes, chpsg aims to investigate the prevalence, clinical characteristics, natural history, and risk factors of htg-ap in china. the consortium will also explore the differences between htg-ap and other etiologies of pancreatitis, with an emphasis on systemic and local complications, recurrence, and long-term quality of life. through its phased approach, chpsg seeks to develop targeted strategies for the prevention and treatment of htg-ap, ultimately improving patient outcomes.


Eligibility criteria:
inclusion criteria: * aged between 18 and 80 years; * diagnosed with ap based on at least two of the following criteria (1) acute onset of upper abdominal pain; (2) more than three times the upper limit of the normal range of serum lipase or amylase levels; and (3) typical radiological findings of ap on computed tomography (ct), magnetic resonance imaging, or ultrasonography; * htg with serum triglyceride levels \>500 mg/dl (5.65 mmol/l) during the current ap episode or at admission; * patients must have good compliance, with the ability and willingness to adhere to study protocols, provide written informed consent, and maintain their current lifestyle during the study period exclusion criteria: * history of chronic pancreatitis or pancreatic cancer; * severe comorbidities such as malignancy, acute myocardial infarction, or extensive cerebral infarction; * prior use of lipid-lowering medications; * pregnancy or breastfeeding; * lack of signed informed consent.
xgboost for predict incisional hernia

Conditions: Incisional Hernia

Summary: the objective of this study is to develop a predictive model of ih based on machine learning with the use of the xgboost technique, this will help surgeons in charge of abdominal wall closure to have objective support to determine high-risk patients and in them modify the closure technique or use a mesh according to their choice or the degree of contamination of the abdominal cavity.

retrospective and observational study. the predictions will make using machine learning models. the programs use the scikit-learn, xgboost and catboost python packages for modeling. the evaluation of models will be using fourfold cross-validation, the receiver operating characteristic (roc) curve, the area under the roc curve (auc), and accuracy metrics calculated on the union of the test sets of the cross-validation. the most critical factors and their contribution to the prediction will identify using a modern tool of explainable artificial intelligence called shapley additive explanations (shap).

Eligibility criteria:
inclusion criteria: * patients older than 18 years of age * postoperative midline exploratory laparotomy, who underwent urgent or scheduled surgery, regardless of their underlying diagnosis, * included between january 2010 and december 2016 and who completed 24 months of follow-up after surgery initial surgery. exclusion criteria: * reoperated for any cuestion diferent to present of hernia * management of open abdomen